By STEVE MITCHELL UPI Senior Medical Correspondent WASHINGTON, June 8
(UPI) -- An animal rights group says a recent U.S. Department of
Agriculture report vastly underestimates the number of animals in
research facilities, and the organization is pushing for the passage of
new legislation that could ultimately make drug discovery more expensive
for industry. The USDA, which is charged with overseeing humane
treatment of animals in research facilities, said in a report posted on
its Web site that there are more than 1 million primates, dogs, cats and
other species in research facilities. A separate report shows there were
more than 20,000 violations last year of the law requiring proper care
and treatment of animals in research facilities.

The animal rights group, Stop Animal Exploitation Now, says the USDA
reports do not include animals used for breeding and conditioning and
also may underreport animals subjected to painful or distressing
experiments without the benefit of anesthesia or pain-relieving
medications.

"The USDA doesn't want the public to know the extent of violations or
even the extent of animals in research facilities," Michael Budkie,
executive director of SAEN, told United Press International.

The reason research facilities may underreport the number of animals
subjected to painful experiments without pain relief is that they would
then have to disclose the nature of the study and explain why they
withheld anesthesia, Budkie said.

These types of experiments in primates can include bolting a device
to their skull, restraining them to a chair for several hours and
withholding food and water for extended periods of time, he said.

Failing to properly care for animals could make animal research
unreliable, which could ultimately lead to human experiments or
medications that are less safe than they seem, Budkie charged.

"If you're performing research on animals that are highly stressed
are unhealthy, it would have to make research less dependable," he said.
"The research probably wouldn't generalize to members of the same
species let alone give you information that could be useful in human
medicine."

Budkie said biotech and pharmaceutical companies should want to
ensure the humane treatment of lab animals to improve the quality of the
information they get from preclinical studies. "But they generally want
to look the other way because it would result in higher costs," he said.

Budkie charged that by leaving out the animals used for breeding and
conditioning, the USDA report does not include half of the animals at
some facilities. As an example, he said the USDA report lists
approximately 57,000 primates in U.S. labs but the real total is closer
to 110,000-120,000.

The undercounting happens on the state level, too, Budkie maintained,
citing South Carolina; the USDA reports experiments on 440 primates in
the entire state. But Yemassee, S.C.-based Labs of Virginia alone has
nearly 5,400 primates, he said.

"The same kind of thing happens in at least 14 states," Budkie said.

The USDA and industry denied the allegations.

USDA spokesman Jim Rogers told UPI the agency's report includes what
is required by law, so there is nothing untoward about the results of
its tally.

In addition, Rogers said, the problems cited in one of the reports
are not violations but something the agency calls noncompliance issues.
The report, however, is entitled "Violation Summary" and includes a
"violation count" column.

"Those aren't violations," Rogers said. "When we do an inspection, we
write everything down that is outside of regulations. If they fix them,
they're not a problem. If they don't, we go to court ... and then it
could become a violation."

But a noncompliance issue generally won't result in a violation.
"It's not an easy thing to get a violation," he said.

Frankie Trull, president of the Foundation for Biomedical Research, a
group supported by industry, told UPI the USDA count may actually give
an inflated tally of the number of animals in research labs.

"The number USDA uses is actually an overestimate of the number of
animals because animals that may be in long-term studies may get counted
multiple number of times," Trull said.

In addition, she said many infractions are for minor issues, such as
peeling paint, that may have no bearing on the well-being of the
animals.

"I think it's the broad consensus of both the USDA and the research
community the inspection enforcement program is really working
remarkably well," Trull said.

She added that aside from SAEN, she has not heard other animal rights
groups complaining about this issue. "So I think it's a little bit of a
non-story," she said.

Budkie said steeper fines would help curtail the violations of animal
welfare laws. His group and the Humane Society of the United States are
supporting a congressional bill called the Animal Protection
Accountability Improvement Act that was introduced in the House last
month. The largest current fine is $2,500, but the new legislation would
increase that to $10,000 and each animal would be considered an
additional fine.

Trull said her group has not yet taken a position on the legislation
but that it could hinder biomedical research with severe penalties that
may not be warranted in some cases.

For example, she said, a single infraction for peeling paint in a
room with 12 animals in it could result in a fine of $120,000 under the
new legislation. "I don't think that makes any sense," she said.

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